You are on page 1of 88

AT 030

Applanation tonometer

Documentation set
Copyright
©2020, Carl Zeiss Meditec AG, Jena

Trademarks
All trademarks mentioned in this document are the property of
their respective owners.
Contents

Instruction for use


AT 030 Applanation tonometer
1
[319300-9120-000-GA-GB-240320]

Instructions for use and disinfection


of tonometer measuring prisms
2
[319300-9231-000-AddGA01-GB-240320]

319300-9120-000-Inhalt0-GB-240320
Contents

Instruction for use


AT 030 Applanation tonometer
1
[319300-9120-000-GA-GB-240320]

319300-9120-000-Inhalt1-GB
AT 030
Applanation tonometer

Instruction for use


Instruction for use Contents
AT 030

Contents
1 Notes on the instructions for use ............................................................... 5
1.1 Product name .................................................................................................................... 5
1.2 Scope of application .......................................................................................................... 5
1.3 Purpose and storage of the documentation ...................................................................... 5
1.4 Questions and comments .................................................................................................. 5
1.5 Conventions in this document ........................................................................................... 5
1.5.1 Conventions in all text areas.......................................................................................................... 5
1.5.2 Conventions in a course of action.................................................................................................. 6
1.6 Applicable documents ....................................................................................................... 6

2 Safety notes ............................................................................................... 7


2.1 Intended user profile ......................................................................................................... 7
2.2 Area of use ........................................................................................................................ 7
2.2.1 Indication for use .......................................................................................................................... 7
2.3 Responsibilities and duties of the operator ....................................................................... 7
2.3.1 Messages to manufacturer and authorities .................................................................................... 8
2.4 Measures and duties of the operator................................................................................. 8
2.5 Maintenance measures...................................................................................................... 9

3 Description of the device............................................................................ 11


3.1 Package check list ............................................................................................................. 11
3.2 Device marking ................................................................................................................. 11
3.3 Structure of the device ...................................................................................................... 12
3.4 Functional description ....................................................................................................... 13

4 Installation ................................................................................................. 15
4.1 Installation safety .............................................................................................................. 15
4.2 General information .......................................................................................................... 15
4.3 Mounting the device on SL 800 slit lamp using the swivel-mounted tonometer holder on
the stereomicroscope or Fundus VarioView ...................................................................... 16
4.4 Mounting the device to the SL 120, SL 130 and SL 220 slit lamps using the swivel-
mounted tonometer holder behind the stereomicroscope................................................. 18
4.5 Mounting the device on SL 120, SL 130, SL 220, and ZEISS VISULAS laser slit lamps
using the fixed tonometer holder ...................................................................................... 20

5 Daily startup............................................................................................... 23
5.1 Preparation safety ............................................................................................................. 23
5.2 Measuring spherical corneal surfaces ................................................................................ 24

319300-9120-000-GA-GB-240320 3 / 60
Contents Instruction for use
AT 030

5.3 Measuring toric cornea surfaces........................................................................................ 24


5.4 Preparing for measurement............................................................................................... 24
5.5 Measurement with AT 030 ................................................................................................ 26
5.6 Conversion table for tonometer readings .......................................................................... 28

6 Cleaning and disinfection ........................................................................... 31


6.1 Safety when cleaning and disinfecting the device ............................................................. 31
6.2 Cleaning ............................................................................................................................ 31

7 Maintenance .............................................................................................. 33
7.1 Metrological check ............................................................................................................ 33
7.2 Adjusting the swivel-mounted tonometer holder with square mounting interface
(version a).......................................................................................................................... 34
7.3 Adjusting the swivel-mounted tonometer holder with round mounting interface (version
b) ....................................................................................................................................... 39
7.4 Checking the device........................................................................................................... 44

8 Troubleshooting......................................................................................... 47

9 Technical specifications.............................................................................. 51
9.1 Compliance........................................................................................................................ 51
9.1.1 Directives with which the device is compliant ................................................................................ 51
9.1.2 Classification of the device ............................................................................................................ 51
9.2 Device data........................................................................................................................ 51
9.3 Dimensions and weights.................................................................................................... 52
9.4 Ambient requirements....................................................................................................... 52

10 Optional accessories................................................................................... 53

11 Disposal of the device ................................................................................ 55

Glossary ..................................................................................................... 57

Index .......................................................................................................... 59

4 / 60 319300-9120-000-GA-GB-240320
Instruction for use 1 Notes on the instructions for use
AT 030 1.1 Product name

1 Notes on the instructions for use

1.1 Product name


AT 030 applanation tonometer is referred to as "device" in these
instructions for use.

1.2 Scope of application


The present instructions for use apply to AT 030 applanation
tonometer with the following labeling:
• Reference number: 319300-9120-000

1.3 Purpose and storage of the documentation


These instructions for use explain the safety features, functions and
performance parameters of the device. They contain instructions on
the safe use of the device and identify measures for its care and
maintenance.
Correct operation of the device is imperative for its safe and
successful functioning.
u Read these instructions for use before setting up and using the
device the first time.
u Keep the instructions for use accessible for all users at all times.
u Pass the instructions for use to future owners of the device.

1.4 Questions and comments


u If you have questions or comments concerning these instruc-
tions for use or the device itself, contact ZEISS Service.
You can find the ZEISS contact partner for your country on the
following website: www.zeiss.com/med

1.5 Conventions in this document


Certain types of information are specially marked in this document
for better recognition.

1.5.1 Conventions in all text areas


• This is a list.
– This is a second level list.
This is a cross-reference: Questions and comments [} 5].
This is highlighted text.
This is software code or program text.

319300-9120-000-GA-GB-240320 5 / 60
1 Notes on the instructions for use Instruction for use
1.6 Applicable documents AT 030

Names of software dialogs, fields or menus, and software


messages are marked by quotation marks:
• "View" menu.
• "Do you want to save the settings?"
The steps in menu and file paths are separated by slashes:
• "File / Save as"
• "My documents / Documents"
Keys, buttons, knobs, levers and other operating controls are
marked by square brackets:
• [START] key
• [Next] button

1.5.2 Conventions in a course of action

This is warning information about hazards that can cause


WARNING! death or severe injuries if not avoided.
The warning message names the possible consequences.
u This is a measure with which hazards can be prevented.

This is warning information about hazards that can cause


CAUTION! injuries if not avoided.
The warning message names the possible consequences.
u This is a measure with which hazards can be prevented.

This is warning information about hazards that can cause


NOTE property damages if not avoided.
The warning message names the possible consequences.
u This is a measure with which hazards can be prevented.
þ This is a requirement that must be met before the start of a
sequence of actions.
1. This is a command.
2. CAUTION! This is a warning message about hazards that
can occur during a single action. This is a command.
ð This is the result of a sequence of actions.

1.6 Applicable documents


Please also refer to the instructions for use for additional compo-
nents and accessories to be used with this device.

6 / 60 319300-9120-000-GA-GB-240320
Instruction for use 2 Safety notes
AT 030 2.1 Intended user profile

2 Safety notes

2.1 Intended user profile


The device may only be installed, operated, used and maintained by
persons who have the necessary training, knowledge and
experience to do so. Please also adhere to the national qualification
guidelines applicable in your country.
Persons who operate the device must have knowledge of basic
ophthalmic examination and diagnosis methods as well as of
ophthalmic optics. This includes, among others, persons belonging
to the following occupational groups or their national equivalents:
• Ophthalmologist
• Optometrist

2.2 Area of use

2.2.1 Indication for use


The AT 030 applanation tonometer is for measuring the intraocular
pressure of a seated patient.

2.3 Responsibilities and duties of the operator

Operating personnel
The device may only be operated by instructed and trained
personnel.
u Ensure that the operating personnel have been trained and
instructed.
u Ensure that the operating personnel have read and understood
the instructions for use.
u The instructions for use should be readily accessible to the
operating personnel at all times.
u To facilitate access for the entire operating personnel: If
necessary, request further copies of the instructions for use
from ZEISS.
u Define the required skills for handling the device and provide
information on who is authorized for which activities.
u Define rules for reporting errors and damage, and provide
information on these. Notification to manufacturers and
authorities [} 8]
u Regularly check compliance with the national laws and regula-
tions concerning accident prevention and occupational health.

319300-9120-000-GA-GB-240320 7 / 60
2 Safety notes Instruction for use
2.4 Measures and duties of the operator AT 030

Maintenance and inspection


u To ensure safe operation of the device and reach the expected
service life: Observe the maintenance and inspection intervals
that are specified in these instructions for use.

Modifications to the product


Modifications to the product or failure to follow the manufacturer’s
instructions may substantially reduce the expected service life and
significantly increase the risks associated with the use of this device
and are thus not permitted.

Accessories and additional equipment


u If you want to connect accessories or additional equipment to
the device: Contact your ZEISS representative [} 5].

2.3.1 Messages to manufacturer and authorities


If a serious incident occurs in connection with this medical device
affecting the operator or another person, the operator (or person
responsible) must report this serious incidence to the manufacturer
or seller of the medical product. In the European Union, the
operator must report this serious incident to the responsible
authorities in the applicable country.

2.4 Measures and duties of the operator

Ambient conditions
u Make sure that the installation conditions and the operation of
the device comply with the surgical requirements:
• Low vibration
• Clean environment
• Avoid extreme mechanical loads
u Do not store or use this device in damp areas. Do not expose
the device to water splashes, dripping water or sprayed water.
u Ensure that no liquids can enter the device.

Symbols and labels


u Observe the symbols and labels attached to the device.

8 / 60 319300-9120-000-GA-GB-240320
Instruction for use 2 Safety notes
AT 030 2.5 Maintenance measures

Transport
u When assembling or transporting the AT 030 applanation
tonometer, the measuring element must be set to 2.0 using the
rotary knob. Only in this way the measuring arm with the
measuring prism holder will be at a defined position.
u Transport the device over long distances (e.g. move, return for
repair, etc.) only in original packaging or special return
packaging.
u Contact your dealer or ZEISS Service.

2.5 Maintenance measures


Maintenance procedures (maintenance and repairs) which are not
specified in these instructions for use may only be carried out by
persons authorized by Carl Zeiss Meditec and solely according to
the service instructions issued by Carl Zeiss Meditec. For planning
and implementing these maintenance and care procedures please
contact ZEISS Service or your local dealer.

319300-9120-000-GA-GB-240320 9 / 60
Empty page, for your notes
Instruction for use 3 Description of the device
AT 030 3.1 Package check list

3 Description of the device

3.1 Package check list


The scope of delivery of the AT 030 applanation tonometer
includes the following components:
• AT 030 applanation tonometer
• Box with measuring prisms and test weights
• Documentation set

3.2 Device marking


Labels Explanation
AT 030 type label

Manufacturer

Date of manufacture

Disposal advice for EU

AT 030 identification label

REF Catalog/part number

SN Serial number

Label with manufacturing date

Sign with scale value

319300-9120-000-GA-GB-240320 11 / 60
3 Description of the device Instruction for use
3.3 Structure of the device AT 030

3.3 Structure of the device


10

3
8

4
6
5 5

Figure 1: Control elements of the AT 030 applanation tonometer and the


swivel-mounted/fixed tonometer holder

1 AT 030 applanation 2 Rotary knob of graduated


tonometer drum

3 Knurled screw 4 Base plate of fixed tonometer


holder

5 Alignment holes 6 Base plate of swivel-mounted


tonometer holder

7 Centering pin 8 Readout scale

9 Extensible measuring prism 10 Measuring prism


holder

12 / 60 319300-9120-000-GA-GB-240320
Instruction for use 3 Description of the device
AT 030 3.4 Functional description

3.4 Functional description


The AT 030 applanation tonometer may only be used according to
its indication for use if it is used in combination with a slit lamp. In
this combination, the slit lamp fulfills the following functions:
mechanical attachment of the tonometer, illumination and
magnified observation of the produced measuring pattern. During
operation, the ZEISS slit lamp does not have any impact on the
applanation tonometer, neither has the applanation tonometer any
impact on the functioning of the ZEISS slit lamp.
Following ZEISS slit lamps are compatible to AT 030: SL 120,
SL 130, SL 220, SL 800 and ZEISS VISULAS laser slit lamps.
The AT 030 applanation tonometer was designed for ZEISS slit
lamps according to the principle applied by Professor Goldmann.
The measuring device, containing a measuring prism with built-in
optical doubling system, is mounted on the slit lamp using a
dedicated tonometer holder and the applanation surface is
observed through the microscope of the slit lamp.
Further progress has been achieved by the use of a comparatively
small applanation surface requiring only small measuring forces, as
introduced by Professor Goldmann.
Professor Goldmann discovered that the counteracting forces of
corneal rigidity and capillary attraction of tear fluid neutralize each
other at an applanation surface of 3.06 mm diameter, so that the
applied force corresponds to the intraocular pressure.
The AT 030 works on the principle of force variation due to the
expansion of a spring. Therefore, it does not require any mainte-
nance or readjustment.
The measurement accuracy and repeatability of the AT 030
measuring results corresponds to the requirements of
ISO 8612:2009.

319300-9120-000-GA-GB-240320 13 / 60
Empty page, for your notes
Instruction for use 4 Installation
AT 030 4.1 Installation safety

4 Installation

4.1 Installation safety

Damage during assembly, cleaning and transport


NOTE
The device can be damaged during assembly, cleaning and
transport if the measuring arm with the measuring prism holder is
not at a defined position.
u When assembling, cleaning or transporting the AT 030 appla-
nation tonometer, the measuring element must be set to 2.0.
NOTE! The device may be used only for seated patients, i.e.
in horizontal measuring direction.

4.2 General information


The device can be mounted on ZEISS slit lamps by using a special
tonometer holder. Special tonometer holders have been specifically
developed for the use of the AT 030 with ZEISS slit lamps and can
be purchased separately.
The tonometer holder permits observation of the measuring prism
through the left or right eyepiece of the slit lamp microscope. For
this purpose, AT 030 is plugged into the alignment holes on the
base plate.
The easily replaceable measuring prism of AT 030 contains an
optical system that divides the image of the applanation surface in
two halves.
The measuring force applied to the eye via the measuring prism can
be adjusted between 0 mN and 78 mN by turning the rotary knob
of the graduated drum. The scale value is 0.98 mN.
For movements towards the patient, the device has a spring-loaded
stop to avoid injuries arising from inadvertently coming too close to
the eye. Restricted visual acuity of the operator can be compen-
sated for by using adjustable eyepieces on the slit lamp.

319300-9120-000-GA-GB-240320 15 / 60
4 Installation Instruction for use
4.3 Mounting the device on SL 800 slit lamp using the swivel-mounted tonometer AT 030
holder on the stereomicroscope or Fundus VarioView

4.3 Mounting the device on SL 800 slit lamp using


the swivel-mounted tonometer holder on the
stereomicroscope or Fundus VarioView

Damage due to improper assembly


NOTE
u After assembly, make sure the device and tonometer holder are
firmly seated.
Action 1. Position the tonometer holder with the guide pins on the
stereomicroscope or, if mounted, on the Fundus VarioView
such that the mounting pivot points to the headrest
2. Attach the mounted tonometer holder using the size 3 screw-
driver, supplied.
3. Attach the device to the base plate of the tonometer holder
and fix it by means of the knurled screw.
4. Ensure that the centering pin is securely seated into one of the
two alignment holes. Select the alignment hole on the side
where the eyepiece is to be used. If the tonometer holder is
adjusted correctly the measuring prism will be visible in the
center of the eyepiece.
HINT: The applanation tonometer with the base plate of the swivel-
mounted tonometer holder can easily be swung out of the optical
path by turning it laterally to the right around its vertical axis A.
This enables unhindered work with the slit lamp. Additionally, the
extensible measuring prism holder can be pushed into the
tonometer. The measuring prism holder should then be in its
bottom end position.

16 / 60 319300-9120-000-GA-GB-240320
Instruction for use 4 Installation
AT 030 4.3 Mounting the device on SL 800 slit lamp using the swivel-mounted tonometer
holder on the stereomicroscope or Fundus VarioView

2 A

Figure 2: Mounting the AT 030 to the SL 800 slit lamp with swivel-mounted tonometer holder

1 Swivel-mounted tonometer holder 2 Guide pin

3 Knurled screw 4 Base plate of tonometer holder

319300-9120-000-GA-GB-240320 17 / 60
4 Installation Instruction for use
4.4 Mounting the device to the SL 120, SL 130 and SL 220 slit lamps using the AT 030
swivel-mounted tonometer holder behind the stereomicroscope

4.4 Mounting the device to the SL 120, SL 130 and


SL 220 slit lamps using the swivel-mounted
tonometer holder behind the stereomicroscope

Damage due to improper assembly


NOTE
u After assembly, make sure the device and tonometer holder are
firmly seated.
NOTE! If accessory units have been mounted between the
microscope and tube, the tonometer holder must always be
attached directly to the microscope!
Action 1. Remove the binocular tube from the slit lamp.
2. Attach the tonometer holder to the slit lamp.
3. Attach the applanation tonometer to the base plate of the
tonometer holder and fix it by means of the knurled screw.
4. Ensure that the centering pin is securely seated into one of the
two alignment holes. Select the alignment hole on the side
where the eyepiece is to be used. If the tonometer holder is
adjusted correctly the measuring prism will be visible in the
center of the eyepiece in use.
HINT: The applanation tonometer with the base plate of the swivel-
mounted tonometer holder can easily be swung out of the optical
path by turning it laterally to the right around its vertical axis A.
This enables unhindered work with the slit lamp. Additionally, the
extensible measuring prism holder can be pushed into the
tonometer. The measuring prism holder should then be in its
bottom end position.

18 / 60 319300-9120-000-GA-GB-240320
Instruction for use 4 Installation
AT 030 4.4 Mounting the device to the SL 120, SL 130 and SL 220 slit lamps using the
swivel-mounted tonometer holder behind the stereomicroscope

2 3

A 1
A

Figure 3: Mounting the AT 030 on ZEISS slit lamps with swivel-mounted tonometer holder behind the stereo-
microscope e.g. SL 120 (left) and SL 220 (right)

1 AT 030 applanation tonometer 2 Swivel-mounted tonometer holder, version a


(square mounting interface)

3 Swivel-mounted tonometer holder, version b A Vertical axis


(round mounting interface)

319300-9120-000-GA-GB-240320 19 / 60
4 Installation Instruction for use
4.5 Mounting the device on SL 120, SL 130, SL 220, and ZEISS VISULAS laser slit AT 030
lamps using the fixed tonometer holder

4.5 Mounting the device on SL 120, SL 130, SL 220,


and ZEISS VISULAS laser slit lamps using the
fixed tonometer holder

Damage due to improper assembly


NOTE
u After assembly, make sure the device and tonometer holder are
firmly seated.
Action 1. Remove the cap from the swivel arm of the slit projector.
2. Plug the centering pivot of the tonometer holder into centering
aperture so that mounting plate faces the patient side.
3. Attach the applanation tonometer to the base plate of the
tonometer holder and fix it by means of the knurled screw.
4. Ensure that the centering pin is securely seated into one of the
two alignment holes. Select the alignment hole on the side
where the eyepiece is to be used.
NOTE! The measuring prism must be visible in the center of
the eyepiece being used. Correct any lateral misalignment of
the tonometer by slightly turning the tonometer holder.
If the correct position of the tonometer has been found, fasten the
tonometer holder with the two fastening screws in the holes
provided.
HINT: If the device is used on ZEISS slit lamps using the fixed
tonometer holder it cannot be swung out of the observation path.
The device may, however, be easily removed from the slit lamp
prior to diagnosis or treatment by loosening the knurled screw. The
tonometer holder can remain on the slit lamp.

20 / 60 319300-9120-000-GA-GB-240320
Instruction for use 4 Installation
AT 030 4.5 Mounting the device on SL 120, SL 130, SL 220, and ZEISS VISULAS laser slit
lamps using the fixed tonometer holder

1 8

7
2
6

3 4 5

Figure 4: Mounting the AT 030 to ZEISS slit lamps using the fixed
tonometer holder

1 Cap 2 Swivel arm of slit projector

3 Centering aperture 4 Centering pivot

5 Fixing screws 6 Mounting plate

7 Tonometer holder base plate 8 Knurled screw

319300-9120-000-GA-GB-240320 21 / 60
Empty page, for your notes
Instruction for use 5 Daily startup
AT 030 5.1 Preparation safety

5 Daily startup

5.1 Preparation safety

Risk due to contaminated or damaged measuring prisms


CAUTION!
The patient may be injured by contaminated or damaged
measuring prisms.
u Never use damaged measuring prisms!
u Only use clean, residue-free and undamaged measuring prisms.
u Prior to every use, the contact surface of the measuring prism
must be inspected for contaminants and damage (scratches,
cracks or sharp edges). This must be performed with a slit lamp
microscope at a medium magnification (e.g. 12x or 16x).

Risk of non-compliance with contraindications


CAUTION!
The patient may be injured or suffer complications if the contraindi-
cations are ignored.
u The device should not be used if the patient is susceptible to
the anesthetic used for the tonometry.
u Utmost caution is also advised with patients suffering from
corneal epithelium lesions.
u Utmost caution is also advised with patients with keratitis,
infection of the cornea or penetrating eye injuries.

Risk due to measuring errors


CAUTION!
Measurements with a damaged tonometer may be faulty.
u Check the tonometer for visible damage as described in the
chapter Checking the tonometer [} 44].
Prior to using the device, the user must ensure that it is in a good
condition and fully functioning. Furthermore, the user must follow
the instructions in the user manual.
NOTE! The tonometric measurement should be taken in a
darkened room and the slit lamp operated at normal lamp
intensity. Only under these conditions is it possible to repro-
ducibly observe the weakly shining inner edge of the
fluorescein ring. To ensure that the scale can also be seen in
darkened rooms, it is set against a green fluorescent
background.
NOTE! The actual measuring process should take no longer
than 30 seconds, otherwise the pressure will be reduced by
flowing processes.

319300-9120-000-GA-GB-240320 23 / 60
5 Daily startup Instruction for use
5.2 Measuring spherical corneal surfaces AT 030

5.2 Measuring spherical corneal surfaces


With a spherical cornea, the applanation surface is a circle. The
optical system generates two fluorescein semicircles to be coinci-
denced.
The measuring prism has a graduated scale. The measuring prism
holder has a white and a red index line.
With spherical cornea, rotate the measuring prism until the 0° line
of the angle scale coincides with the white index line of the
measuring prism holder. In this case, the line of coincidence of the
measuring prism is horizontal.

5.3 Measuring toric cornea surfaces


With a toric cornea, the applanation surface is an ellipse. The
coincidence of the half ellipses provides correct pressure values only
if the surface of the ellipse is equal to the surface of the appla-
nation circle. This condition is to be met for a definite angular
position of the major semiaxis of the ellipse with regard to a
principal direction of curvature of the cornea. The calculation
shows that an astigmatism of below 3 D is negligible for tonometer
measurement. With higher astigmatism, correct measurements are
taken at an angle of about 43° between the major diameter of the
ellipse and the direction of the minor principal section.
The measuring prism has a graduated scale. The measuring prism
holder has a white and a red index line.
Astigmatism is taken into account as follows:
Action u With an astigmatism up to 3 D, rotate the measuring prism
until the 0° line of the angle scale coincides with the white
index line of the measuring prism holder. In this case, the
separating line of the measuring prism is horizontal.
u With astigmatism above 3 D, the axial position of the lower
refracting principal section (larger radius of curvature) must be
known from a previous measurement with an ophthalmometer.
Set the corresponding axis angle at the angle scale of the
measuring prism to the red index line of the measuring prism
holder. In this setting, the separating line of the measuring
prism forms an angle of 43° to the horizontal.

5.4 Preparing for measurement

Risk due to improper locking of the slit lamp


CAUTION!
The patient may be injured if the slit lamp moves during the
measurement.
u Ensure that the instrument table is horizontal to avoid
movement of the slit lamp with attached measuring prism
towards the patient.

24 / 60 319300-9120-000-GA-GB-240320
Instruction for use 5 Daily startup
AT 030 5.4 Preparing for measurement

NOTE! Always anesthetize both eyes to avoid eyelid blinking.


NOTE! The application of too much fluorescein solution
results in readings that are too high, whereas too little
fluorescein solution results in narrow semicircles, thus
producing readings that are too low.
Action u Calm the patient to take away his/her fear of the examination
as this fear may cause an increased intraocular pressure.
Therefore, do not use the result of the first trial measurement
on both eyes, but take the average of the subsequent three
measurements of each eye to obtain a reproducible result.
u Administer usual anesthesia of the cornea of the patient’s eye
prior to measurement.
u Then apply a drop of fluorescein solution to the conjunctival
sac of the patient’s eye, using a strip of blotting paper as
necessary, to produce a green fluorescing band of liquid
around the measuring surface in the following measurement.
u Ask the patient to look towards the front surface of the
measuring prism. If necessary, the fixation lamp can be used to
calm the eyes.
u Record the date and time of each tonometer measurement and
the period that has passed since the last application of
pressure-reducing substances.

319300-9120-000-GA-GB-240320 25 / 60
5 Daily startup Instruction for use
5.5 Measurement with AT 030 AT 030

5.5 Measurement with AT 030

1 2

Figure 5: Controls of the AT 030

1 Measuring prism 2 Extensible measuring arm


with measuring prism holder

3 Rotary knob of graduated 4 Readout scale


drum

Action 1. Position the patient’s head in front of the slit lamp using the
height adjustment of the head rest so that the eyes are level
with the red marking of the head rest.
The patient’s head must be pressed firmly against the head
rest.
2. Insert the clean and disinfected measuring prism into the
measuring prism holder as far as it will go. Hold the measuring
prism holder while doing so. Make sure that the extensible
measuring arm does not collide with the front or back limit
position of the motion range.
NOTE! The measuring prism has a graduated scale. The
measuring prism holder has a white and a red index line.
Please note the corresponding angle adjustment when
measuring spherical and toric curved corneal surfaces (see
also Measuring spherical corneal surfaces [} 24] and Measuring
toric cornea surfaces [} 24]).

26 / 60 319300-9120-000-GA-GB-240320
Instruction for use 5 Daily startup
AT 030 5.5 Measurement with AT 030

3. Pull the extensible measuring arm with measuring prism holder


up to the upper end position and then rotate it by 90° towards
the patient’s side. The upper end position is reached after
overcoming a slight resistance.
4. Position the applanation tonometer in the beam path. Set the
rotary knob of the graduated drum to scale reading 1 so that
the measuring prism is in its front end position.
5. Swivel the slit projector about 60° to the side. Open the slit
completely and switch the blue filter on. Swivel in the optional
yellow filter to observe the measuring pattern with improved
contrast.
Observe the measurement through the selected eyepiece at a
medium magnification (e.g. 12x or 16x).
6. Ask the patient to open his/her eyes wide. You can assist by
splaying out the patient’s eyelid with thumb and forefinger.
Take care, however, not to exert inadvertent pressure on the
bulbus. The fingers should rest only on the bony eye socket.
7. Adjust the measuring prism using the joystick of the slit lamp
vertically and horizontally to the patient’s eye.
NOTE! The axis of the measuring prism is set at an angle of
approx. 6° to the axis of the slit lamp. Ask the patient to
look towards the measuring prism so that the measuring
prism can touch the corneal vertex centrally.

Figure 6: Measuring patterns produced by the applanation tonometer


8. Vary the measuring force by turning the rotary knob of the
graduated drum until the inner edges of the green semicircles
touch each other. The two semicircles must be of equal size,
and pulsate uniformly. In this setting, the applanation surface
has the nominal diameter of 3.06 mm. If the measuring force
has been set too high, a different pattern appears, as in Figure
c. If the measuring force has been set too low, the pattern will
be as in Figure a.
9. Multiplied by 10, the value read directly from the scale of the
graduated drum gives the intraocular pressure in mm Hg (see
Conversion table for tonometer readings [} 28]).

319300-9120-000-GA-GB-240320 27 / 60
5 Daily startup Instruction for use
5.6 Conversion table for tonometer readings AT 030

5.6 Conversion table for tonometer readings


Scale reading Pressure
mmHg kPa* mbar
0.2 2.0 0.27 2.7

0.4 4.0 0.53 5.3

0.6 6.0 0.80 8.0

0.8 8.0 1.07 10.7

1.0 10.0 1.33 13.3

1.2 12.0 1.60 16.0

1.4 14.0 1.87 18.7

1.6 16.0 2.13 21.3

1.8 18.0 2.40 24.0

2.0 20.0 2.67 26.7

2.2 22.0 2.93 29.3

2.4 24.0 3.20 32.0

2.6 26.0 3.47 34.7

2.8 28.0 3.73 37.3

3.0 30.0 4.00 40.0

3.2 32.0 4.27 42.7

3.4 34.0 4.53 45.3

3.6 36.0 4.80 48.0

3.8 38.0 5.07 50.7

4.0 40.0 5.33 53.3

4.2 42.0 5.60 56.0

4.4 44.0 5.87 58.7

4.6 46.0 6.13 61.3

4.8 48.0 6.40 64.0

5.0 50.0 6.67 66.7

5.2 52.0 6.93 69.3

5.4 54.0 7.20 72.0

5.6 56.0 7.47 74.7

5.8 58.0 7.73 77.3

28 / 60 319300-9120-000-GA-GB-240320
Instruction for use 5 Daily startup
AT 030 5.6 Conversion table for tonometer readings

Scale reading Pressure


mmHg kPa* mbar
6.0 60.0 8.00 80.0

6.2 62.0 8.26 82.6

6.4 64.0 8.53 85.3

6.6 66.0 8.80 88.0

6.8 68.0 9.06 90.6

7.0 70.0 9.33 93.3

7.2 72.0 9.60 96.0

7.4 74.0 9.86 98.6

7.6 76.0 10.13 101.3

7.8 78.0 10.40 104.0

8.0 80.0 10.66 106.6

* 10 Torr = 1.333 kPa = 1333 N/m2

319300-9120-000-GA-GB-240320 29 / 60
Empty page, for your notes
Instruction for use 6 Cleaning and disinfection
AT 030 6.1 Safety when cleaning and disinfecting the device

6 Cleaning and disinfection

6.1 Safety when cleaning and disinfecting the


device
NOTE! The following instructions are only valid for AT 030.
For cleaning and disinfection of tonometer measuring prisms
please refer to the instructions for use and cleaning and
disinfection of tonometer measuring prisms.

Damage during assembly, cleaning and transport


NOTE
The device can be damaged during assembly, cleaning and
transport if the measuring arm with the measuring prism holder is
not at a defined position.
u When assembling, cleaning or transporting the AT 030 appla-
nation tonometer, the measuring element must be set to 2.0.

Damage due to improper cleaning and disinfection


NOTE
Some cleaning agents and disinfectants may have an adverse effect
on plastic components. Damage caused by such disinfectants is not
covered by our warranty.
u Observe the national disinfection regulations.
u Use only disinfectants approved by the manufacturer for the
treatment of plastics and painted surfaces.
u Do not use aggressive (e.g. acetone) or abrasive cleaning
agents.

6.2 Cleaning
Only clean the outer surfaces of the AT 030. A cloth slightly
moistened (not dripping) with diluted detergent is recommended
for cleaning the casing.

319300-9120-000-GA-GB-240320 31 / 60
Empty page, for your notes
Instruction for use 7 Maintenance
AT 030 7.1 Metrological check

7 Maintenance

7.1 Metrological check

AT 030 applanation tonometer


All ZEISS applanation tonometers are metrologically checked and
delivered in this state.

Risk due to measuring errors


CAUTION!
During the service life of the device the user is responsible for
having it metrologically tested in compliance with national regula-
tions.
u In the case of malfunctions, immediately remove the device
from operation and consult ZEISS Service.
NOTE! In Germany, the Medical Devices Operating Ordinance
requires the first inspection no later than 24 months after
the end of the first year of use, or immediately in the case of
impairment of the measurement function by external influ-
ences.
If you wish Carl Zeiss Meditec to perform the metrological check,
please contact ZEISS Service or your local dealer.
NOTE! Please return only cleaned and disinfected device.
The device does not require any maintenance.
Deviation [mN]

Force [mN]

Figure 7: Maximum deviation of measuring accuracy in accordance with


ISO 8612:2009

Tonometer holder
All tonometer holders are adjusted when delivered. With a viewing
magnification of 12x or 16x, the rear surface of the measuring
prism lies concentrically in the field of view of the eyepiece. In the
center of the motion range of the measuring arm the front surface
of the measuring prism is focused in the eyepiece.

319300-9120-000-GA-GB-240320 33 / 60
7 Maintenance Instruction for use
7.2 Adjusting the swivel-mounted tonometer holder with square mounting AT 030
interface (version a)

Lateral and vertical deviations of 1 mm do not impact the pressure


measurement precision.
In the case of greater deviations, first check the following:
Action 1. Is the tonometer positioned in front of the "correct" eyepiece?
2. Is the tonometer holder properly mounted?
3. Has the tonometer holder properly engaged in the operating
position?
If these checks do not yield satisfying results, align tonometer
holders which are mounted behind the stereomicroscope, as
described in section Adjusting the swivel-mounted tonometer
holder with square mounting interface (version a) [} 34] and
Adjusting the swivel-mounted tonometer holder with round
mounting interface (version b) [} 39]. It is not necessary to remove
the tonometer holder with the AT 030 mounted from the slit lamp.
NOTE! If, in case of the swivel-mounted tonometer holder
mounted on the stereomicroscope or Fundus VarioView and
in case of fixed tonometer holders, these checks do not yield
satisfying results, contact ZEISS Service.
Due to manufacturing tolerances (or wear) on the slit lamp it is
possible that, although the tonometer holder has been adjusted
accurately on one side, after shifting to the other side, the
adjustment is unsatisfactory. In this case, repeat adjustments alter-
nately on both sides until it is optimally adjusted in both positions.
NOTE! The adjustment steps can be carried out indepen-
dently of each other in any order. If adjustment according to
the above instructions is not successful, please contact
ZEISS Service.

7.2 Adjusting the swivel-mounted tonometer holder


with square mounting interface (version a)

Preparation
Action u Mount the tonometer holder and AT 030 on the slit lamp.
u Put the AT 030 into the position for the right eyepiece.
u Set the eyepieces of the slit lamp to 0 D or your own correction
value.
u Move the AT 030 to the measuring position.
u Illuminate the measuring prism with the slit lamp projector
from the left to approx. 90°.

34 / 60 319300-9120-000-GA-GB-240320
Instruction for use 7 Maintenance
AT 030 7.2 Adjusting the swivel-mounted tonometer holder with square mounting
interface (version a)

1 2

C 3

5
D

Figure 8: Adjusting options on the swivel-mounted tonometer holder,


version a (square mounting interface)

1 Clamping screw for image A Height adjustment


focus

2 Adjusting screw for height B Coaxial adjustment


adjustment

3 Swivel arm C Image focus

4 Base plate D Lateral adjustment

5 Alignment holes

1 2 3

5 4

Figure 9: Clamping and adjusting screws on the swivel-mounted


tonometer holder,

1 Clamping screws for height 2 Swivel arm


adjustment and coaxial
adjustment

3 Dovetail 4 Clamping screws for


adjusting image focus and
lateral adjustment

5 Swivel arm

319300-9120-000-GA-GB-240320 35 / 60
7 Maintenance Instruction for use
7.2 Adjusting the swivel-mounted tonometer holder with square mounting AT 030

Setting the correct height in the field of view (height


adjustment A)
u Set the magnification of the slit lamp microscope to a high
magnification (e.g. 20x or 25x).
u Loosen the two clamping screws by approx. ½ turn.
u Unscrew the adjusting screw at the upper end of the rod by
approx. 5 mm.
u Press on this adjusting screw and slide the rod with tonometer
downwards, until the base plate is resting on the pivot joint of
the slit lamp.
u Move the tonometer with measuring prism into the vertical
center of the field of view by turning the adjusting screw to the
right. Hold the tonometer, so that it cannot rotate laterally.
Ensure the correct alignment of the measuring prism.
u Firmly retighten the two clamping screws alternately.
u Retighten the adjusting screw carefully.

Adjust height Height adjusted

Setting the alignment (coaxiality B)


u Set the magnification of the slit lamp microscope to a low
magnification (e.g. 5x or 6x).
u Loosen the two clamping screws.
u Observe the measuring prism through the right eyepiece and
set the correct alignment of the measuring prism. Turn the
tonometer, including the base plate, sideways around the rod.
u Firmly retighten the two clamping screws alternately.

Adjust alignment Alignment adjusted Adjust alignment

36 / 60 319300-9120-000-GA-GB-240320
Instruction for use 7 Maintenance
AT 030 7.2 Adjusting the swivel-mounted tonometer holder with square mounting

If the same eyepiece is always to be used for tonometry, the


adjustment is now finished.
If, however, both eyepieces are to be used alternately, the position
of the AT 030 on the base plate must now be changed:
u Release the knurled screw and remove the tonometer.
u Set the tonometer with the centering pin into the other
alignment hole of the base plate.
u Retighten the knurled screw.
u Check, whether the measuring prism is also correctly aligned in
this eyepiece. If not, repeat the first four steps.

Setting/checking the correct focus position (image focus C)


u Set the scale on the tonometer to zero.
u To assess the focus sharpness apply a visible structure to one
side of the front surface of the measuring prism (e.g. finger-
print, dust, graph paper).

319300-9120-000-GA-GB-240320 37 / 60
7 Maintenance Instruction for use
7.2 Adjusting the swivel-mounted tonometer holder with square mounting AT 030

Figure 10: Structure on one side of measuring prism


u Set the magnification of the slit lamp microscope to a high
magnification (e.g. 20x or 25x).
u Set the illumination using the slit projector from the left to
about 90° so that the front of the measuring prism is illumi-
nated.
u Check whether the sharp focus of the visible structure on one
side is in the middle of the motion range by carefully swiveling
the measuring prism from the front to the back stop.
u If the sharp focus position is not correct, loosen the two
clamping screws by approx. ½ turn.
u Push the swivel arm including tonometer forwards or
backwards in the slot until the sharp focus of the structure
visible on one side is in the middle of the motion range. When
moving the tonometer lift it slightly to avoid it tilting under its
own weight.
u Retighten the clamping screws alternately. Start with the rear
clamping screw. Make sure that the measuring prism is in the
center of the field of view.
u Carry out a further check in accordance with step 5.
NOTE! The measuring prism must be visible in the center of
the eyepiece.

38 / 60 319300-9120-000-GA-GB-240320
Instruction for use 7 Maintenance
AT 030 7.3 Adjusting the swivel-mounted tonometer holder with round mounting
interface (version b)

Sharp focus position Sharp focus position Sharp focus position


front set correctly rear

Setting the lateral middle position in the field of view (lateral


adjustment D)
u Set the magnification of the slit lamp microscope to a high
magnification (e.g. 20x or 25x).
u Observe the measuring prism through the microscope (select
proper eyepiece!).
u If the measuring prism is not centered in the field of view,
loosen the two clamping screws on the bottom of the adapter.
u Adjust the measuring prism by swiveling the swivel arms
horizontally in the elongated holes in the center of the field of
view.
u Firmly retighten the clamping screws alternately.

7.3 Adjusting the swivel-mounted tonometer holder


with round mounting interface (version b)

Preparation
Action u Mount the tonometer holder and AT 030 on the slit lamp.
u Put the AT 030 into the position for the right eyepiece.
u Set the eyepieces of the slit lamp to 0 D or your own correction
value.
u Move the AT 030 to the measuring position.
u Illuminate the measuring prism with the slit lamp projector
from the left to approx. 90°.

319300-9120-000-GA-GB-240320 39 / 60
7 Maintenance Instruction for use
7.3 Adjusting the swivel-mounted tonometer holder with round mounting AT 030
interface (version b)

7
3
4
2
C
1

6 5 D

Figure 11: Clamping and adjusting screws on the swivel-mounted


tonometer holder, version b (round mounting interface)

1 Swivel arm A Height adjustment

2 Clamping screw for height B Coaxial adjustment


adjustment and coaxial
adjustment

3 Adjusting screw for height C Image focus


adjustment

4 Set screw for image focus D Lateral adjustment

5 Left set screw

6 Set screw for image focus

7 Base plate

40 / 60 319300-9120-000-GA-GB-240320
Instruction for use 7 Maintenance
AT 030 7.3 Adjusting the swivel-mounted tonometer holder with round mounting

Setting the correct height in the field of view (height


adjustment A)
u Set the magnification of the slit lamp microscope to a high
magnification (e.g. 20x or 25x).
u Loosen the two clamping screws by approx. ½ turn.
u Unscrew the adjusting screw at the upper end of the rod by
approx. 5 mm.
u Press on this adjusting screw and slide the rod with tonometer
downwards, until the base plate is resting on the pivot joint of
the slit lamp.
u Move the tonometer with measuring prism into the vertical
center of the field of view by turning the adjusting screw to the
right. Hold the tonometer, so that it cannot rotate laterally.
Ensure the correct alignment of the measuring prism.
u Firmly retighten the two clamping screws alternately.
u Retighten the adjusting screw carefully.

Adjust height Height set correctly

Setting the alignment (coaxiality B)


u Set the magnification of the slit lamp microscope to a low
magnification (e.g. 5x or 6x).
u Loosen the two clamping screws.
u Observe the measuring prism through the right eyepiece and
set the correct alignment of the measuring prism. Turn the
tonometer, including the base plate, sideways around the rod.
u Firmly retighten the two clamping screws alternately.

Adjust alignment Alignment set Adjust alignment


correctly

319300-9120-000-GA-GB-240320 41 / 60
7 Maintenance Instruction for use
7.3 Adjusting the swivel-mounted tonometer holder with round mounting AT 030

If the same eyepiece is always to be used for tonometry, the


adjustment is now finished.
If, however, both eyepieces are to be used alternately, the position
of the AT 030 on the base plate must now be changed:
u Release the knurled screw and remove the tonometer.
u Set the tonometer with the centering pin into the other
alignment hole of the base plate.
u Retighten the knurled screw.
u Check, whether the measuring prism is also correctly aligned in
this eyepiece. If not, repeat the first four steps.

Setting/checking the correct focus position (image focus C)


u Set the scale on the tonometer to zero.
u To assess the focus sharpness apply a visible structure to one
side of the front surface of the measuring prism (e.g. finger-
print, dust, graph paper).

Figure 12: Structure on one side of measuring prism


u Set the magnification of the slit lamp microscope to 25x.
u Set the illumination using the slit projector from the left to
about 90° so that the front of the measuring prism is illumi-
nated.
u Check whether the sharp focus of the visible structure on one
side is in the middle of the motion range by carefully swiveling
the measuring prism from the front to the back stop.
u If the sharp focus position is only at the front (towards patient),
the swivel arm with tonometer should be moved further
forward:
ð First loosen the two set screws by approx. ¼ turn.
ð Then loosen the two clamping screws by approx. ½ turn.

42 / 60 319300-9120-000-GA-GB-240320
Instruction for use 7 Maintenance
AT 030 7.3 Adjusting the swivel-mounted tonometer holder with round mounting

ð Push the swivel arm including tonometer forwards in the


slot until the sharp focus of the structure visible on one side
is in the middle of the motion range. When moving the
tonometer lift it slightly to avoid it tilting under its own
weight.
ð Then retighten the screws: first, the two set screws, then
both the clamping screws alternately, starting with the rear
clamping screw.
ð Carry out a further check in accordance with step 5.
u If the sharp focus position is only at the rear (towards
observer), the swivel arm with tonometer should be moved
further to the rear:
ð First loosen the two set screws by approx. ¼ turn.
ð Then loosen the two clamping screws by approx. ½ turn.
ð Push the swivel arm including tonometer backwards in the
slot until the sharp focus of the structure visible on one side
is in the middle of the motion range. When moving the
tonometer lift it slightly to avoid it tilting under its own
weight.When moving the tonometer lift it slightly to avoid
it tilting under its own weight.
ð Then retighten the screws: first, the two set screws, then
both the clamping screws alternately, starting with the rear
clamping screw.
ð Carry out a further check in accordance with step 5.
NOTE! The measuring prism must be visible in the center of
the eyepiece.

Sharp focus position Sharp focus position Sharp focus position


front set correctly rear

Setting the lateral middle position in the field of view (lateral


adjustment D)
u Set the magnification of the slit lamp microscope to 25x.
u Observe the measuring prism through the microscope (select
proper eyepiece!).
u If the measuring prism is to the right of the center of the field
of view, proceed as follows:
ð Loosen the right set screw slightly.

319300-9120-000-GA-GB-240320 43 / 60
7 Maintenance Instruction for use
7.4 Checking the device AT 030

ð Then, tighten the left set screw.


ð The left set screw is only accessible if the tonometer holder
is pivoted approx. 30° to the right from the stop notch.
u If the measuring prism is to the left of the center of the field of
view, proceed as follows:
ð Loosen the left set screw slightly.
ð Then, tighten the right set screw. The left set screw is only
accessible if the tonometer holder is pivoted approx. 30° to
the right from the stop notch.
u Adjust alternately until the measuring body can be seen in the
center of the visual field.
u Then retighten both set screws alternately.

Checking the achieved adjustment status


u Perform a final check of the adjustment status.
u If necessary, repeat the steps in sections Setting the correct
height in the field of view (height adjustment A) and Setting
the lateral middle position in the field of view (lateral
adjustment D).
u If required, move the tonometer to the left alignment hole of
the base plate and check the adjustment of the left eyepiece.

7.4 Checking the device


After transport of the device, check the condition of the device as
follows:

Checking while mounted on slit lamp


Action u Move the tonometer to the measuring position.
u Set the scale reading to 0. The measuring prism can easily be
moved back and forth.
u Set the scale reading to 1. The measuring arm with the
measuring prism must move immediately towards the front end
position.
NOTE! If the measuring arm with the measuring prism does
not move to the front end position, discontinue using the
device. Consult ZEISS Service. Please also observe the infor-
mation in the Metrological check [} 33].

44 / 60 319300-9120-000-GA-GB-240320
Instruction for use 7 Maintenance
AT 030 7.4 Checking the device

Detailed check before mounting on the slit lamp

Figure 13: Checking the AT 030

1 Test weight

u Set the scale reading to 0.


u Take the 2 g and 5 g test weights out of the storage box.
u Put the AT 030 onto the open box with the scale facing
downwards.
u Insert the measuring prism inversely up to the normal
measuring position into the measuring prism holder.
u Place a test weight concentrically onto the measuring prism.
u Turn the rotary knob slowly from the 0°-position until the
measuring arm with the weight oscillates weightlessly around
its center position. Remove the test weight.
u Record the corresponding scale value.
u Repeat this procedure four times (two times each from the side
of greater and smaller forces) and calculate the arithmetic
average of the readings.
NOTE! The values obtained with both weights should be 2.0
± 0.06 sc dlv. (2 g weight) and 5.0 ± 0.1 sc dlv. (5 g weight).
If these values cannot be reproduced, discontinue using the
tonometer and consult ZEISS Service. Please also observe the
information in section Metrological check [} 33].

319300-9120-000-GA-GB-240320 45 / 60
Empty page, for your notes
Instruction for use 8 Troubleshooting
AT 030 ​

8 Troubleshooting
Action 1. The axis of the measuring prism must coincide with the normal
to the corneal surface. This is the case if the fluorescein
semicircles are symmetrical to the separating line.
The two fluorescein semicircles are visible in the center of the
eyepiece and touch each other at their inner edges.

Figure 14: Correct measuring pattern


2. If this condition is not met, patterns as shown in the following
figure will appear. These patterns require the slit lamp and thus
the measuring prism to be repositioned laterally and vertically.

Figure 15: Measuring patterns requiring correction of the tonometer


position
Possible faults and their remedies are described below.
Fault Eyepiece Remedy
image
Fluorescein ring too wide/too small

Fluorescein ring too wide: Pull the slit lamp


The measuring prism was not dried back and dry the
after cleaning or the eyelids measuring prism
touched the measuring prism with a lint-free
during measurement. In this case, cloth (e.g. made
the reading is higher than the from cellulose)
actual pressure.

319300-9120-000-GA-GB-240320 47 / 60
8 Troubleshooting Instruction for use
​ AT 030

Fault Eyepiece Remedy


image
Fluorescein ring too small: Let the patient blink
The tear fluid has dried up during and close his/her
a longer measurement. In this case eyes several times
the pressure reading will be too and repeat the
low. measurement.

Incorrect distance to patient

No semicircles visible, only the Instruct the patient


separating line: to press his/her
The measuring prism does not head firmly against
touch the cornea! If the patient the chin- and head
withdraws his/her head slightly, rest.
there will be irregular pulsations as
the measuring prism touches the
eye only intermittently. If the
patient withdraws further, the
fluorescein semicircles will
disappear completely.

Only parts of the two semicircles Retract the slit lamp


are visible as they are too large: until the uniform
If the slit lamp is pushed too far pulsations of a
towards the patient or if the correspondingly
patient moves towards the slit smaller area show
lamp, the measuring arm hits the correct
against a damping spring. The measuring position
applanation area is too large. and pressure
Turning the measuring drum does changes lead
not change the image. directly to surface
changes.

Position too far right/left

Only part of the upper semicircle Move the slit lamp


visible: to the right using
The measuring prism is not the control lever.
centered with the eye. The eye is
too far right.

Whole upper semicircle and part of Move the slit lamp


lower semicircle visible: to the right using
The measuring prism is not the control lever.
centered with the eye. The eye is
too far right.

Only part of the lower semicircle Move the slit lamp


visible: to the left using the
The measuring prism is not control lever.
centered with the eye. The eye is
too far left.

48 / 60 319300-9120-000-GA-GB-240320
Instruction for use 8 Troubleshooting
AT 030 ​

Fault Eyepiece Remedy


image
Only part of the upper semicircle Move the slit lamp
and the entire lower semicircle are to the left using the
visible: control lever.
The measuring prism is not
centered with the eye. The eye is
too far left.

Position too high (too low)

Only part of a semicircle is visible Move the slit lamp


in the upper (lower) half: upwards
The measuring prism is not (downwards) using
centered with the eye. The eye is the control lever.
too far up (down).

Full circle visible in the upper Move the slit lamp


(lower) half: upwards
The measuring prism is not (downwards) using
centered with the eye. The eye is the control lever.
too far up (down).

Almost the whole circle visible at Move the slit lamp


the top (bottom), part of semicircle upwards
visible at the bottom (top): (downwards) using
The measuring prism is not the control lever.
centered with the eye. The eye is
too far up (down).

Two semicircle sections visible, Move the slit lamp


larger visible at top (bottom): upwards
The measuring prism is not (downwards) using
centered with the eye. The eye is the control lever.
too far up (down).

Incorrect pressure

Fluorescein semicircles touch at Turn the measuring


the outer boundaries: drum knob and
Pressure too low. increase the
pressure slightly.

The fluorescein semicircles form a Turn the measuring


ribbon: drum knob and
Slightly too little pressure. increase the
pressure slightly.

The fluorescein semicircles no Turn the measuring


longer touch at the outer bound- drum knob and
aries: lower the pressure
Much too much pressure. slightly.

319300-9120-000-GA-GB-240320 49 / 60
Empty page, for your notes
Instruction for use 9 Technical specifications
AT 030 9.1 Compliance

9 Technical specifications

9.1 Compliance
If modifications not authorized by the manufacturer are made to
the device, this declaration ceases to be valid.

9.1.1 Directives with which the device is compliant


The device complies with the 93/42/EEC Medical devices directive
(MDD)
Device class in accordance with the MDD: I (with measuring
function)

The device is marked with

9.1.2 Classification of the device


UMDNS No.: 16-809
The AT 030 applanation tonometer conforms to the ISO 8612:2009
standard.

9.2 Device data


Value
Measuring prism 2 prisms for image splitting

Diameter of applanation 3.06 mm


surface

Measuring force range of 0 mN to 78.4 mN


precision spring tonometer

Scale reading 0.98 mN

Measurement accuracy according to ISO 8612:2009


9.81 ± 0.49 mN
19.61 ± 0.49 mN
29.42 ± 0.49 mN
39.23 ± 0.59 mN
49.03 ± 0.74 mN
58.84 ± 0.88 mN
68.65 ± 1.03 mN
78.45 ± 1.18 mN

319300-9120-000-GA-GB-240320 51 / 60
9 Technical specifications Instruction for use
9.3 Dimensions and weights AT 030

9.3 Dimensions and weights


Value
Dimensions (W x H x D) 105 mm x 40 mm x 25 mm

Weight 245 g

9.4 Ambient requirements


Value
Ambient conditions for intended use

Temperature +10 °C to +35 °C

Relative humidity 30 % to 75 % (no condensation)

Altitude up to 3000 m above sea level

Ambient conditions for storage

Temperature -10 °C to +55 °C

Relative humidity 10% to 95%

Ambient conditions for transport in original packaging

Temperature -40 °C to +70 °C

Relative humidity 10% to 95%

52 / 60 319300-9120-000-GA-GB-240320
Instruction for use 10 Optional accessories
AT 030 ​

10 Optional accessories
• Swivel-mounted tonometer holder
• Fixed tonometer holder
You can find the ZEISS contact partner for your country on the
following website: www.zeiss.com/med
Use only accessories and spare parts which are approved by ZEISS
for this device. When using accessories and spare parts that are not
approved by ZEISS, safe operation of the device cannot be
guaranteed.
A current and complete list of accessories can be obtained from
your retailer.

319300-9120-000-GA-GB-240320 53 / 60
Empty page, for your notes
Instruction for use 11 Disposal of the device
AT 030 ​

11 Disposal of the device


u Keep packing material in the event of a relocation or repair.
u If you would like to dispose of the original packing material,
send it in for recycling via a recognized collection system.
The system contains electronic components.
u Dispose of the device properly and in accordance with national
legislation.

In accordance with applicable EU guidelines and national regula-


tions at the time at which the product was brought onto the
market, the product specified on the consignment note is not to be
disposed of via the domestic waste disposal system or communal
waste disposal facilities.
u For more information about the disposal of the device, please
contact the ZEISS contact partner in your country.
You can find the ZEISS contact partner for your country on the
following website: www.zeiss.com/med
u If you resell the device or its components: Inform the buyer that
the device is to be disposed of in accordance with the currently
applicable regulations.

319300-9120-000-GA-GB-240320 55 / 60
Empty page, for your notes
Instruction for use Glossary
AT 030

Glossary
D
D (diopter) is the unit of measurement of
the refractive power of optical systems.

kPa
Kilopascal: 1 kPA = 1000 Pa

mbar
Millibar: 1 mbar = 1 hPa = 100 Pa

MDD
Medical Device Directive

mm Hg
Millimeter of mercury column:
measurement of intraocular pressure

319300-9120-000-GA-GB-240320 57 / 60
Empty page, for your notes
Instruction for use Index
AT 030

Index
A
Ambient conditions ................................... 8

D
Disposal
Electronics ............................................ 55
Packaging material................................ 55

I
Intended user profile ................................. 7

O
Operating personnel .................................. 7

P
Product modification ................................. 8

U
User profile................................................ 7

319300-9120-000-GA-GB-240320 59 / 60
Carl Zeiss Meditec AG

Goeschwitzer Strasse 51-52

07745 Jena

Germany

Internet: www.zeiss.com/med

E-Mail: info.meditec@zeiss.com

Specifications subject to change

319300-9120-000-GA-GB-240320
Contents

Instructions for use and disinfection


of tonometer measuring prisms
2
[319300-9231-000-AddGA01-GB-240320]

319300-9120-000-Inhalt2-GB
Instructions for use and disinfection of tonometer
measuring prisms

Addendum
Addendum Table of contents
Instructions for use and disinfection of
tonometer measuring prisms

Table of contents
1 Notes on the instructions for use ............................................................... 5
1.1 Scope of application .......................................................................................................... 5
1.2 Intended use of the document........................................................................................... 5
1.3 Questions and comments .................................................................................................. 5
1.4 Conventions in this document ........................................................................................... 5
1.4.1 Conventions in all text areas.......................................................................................................... 5
1.4.2 Conventions in a course of action.................................................................................................. 6

2 Safety notes ............................................................................................... 7


2.1 Ambient conditions ........................................................................................................... 7
2.2 Important general advice................................................................................................... 7
2.3 Operation, environment .................................................................................................... 7
2.4 Warranty and product liability........................................................................................... 7
2.5 Validated cleaning and disinfecting agents ....................................................................... 8
2.6 List of disinfectants with good material compatibility with ZEISS measuring prisms......... 9
2.7 Service life ......................................................................................................................... 12

3 Cleaning and disinfection of reusable measuring prisms ............................ 13


3.1 Manual cleaning steps ....................................................................................................... 13
3.2 Disinfection steps .............................................................................................................. 14
3.3 Rinsing and storage........................................................................................................... 15

319300-9231-000-AddGA01-GB-240320 3 / 18
Empty page, for your notes
Addendum 1 Notes on the instructions for use
Instructions for use and disinfection of 1.1 Scope of application
tonometer measuring prisms

1 Notes on the instructions for use

1.1 Scope of application


The present addendum applies to tonometer measuring prisms
with the following identification:
• Reference number: 319300-9510-000

1.2 Intended use of the document

Hazard due to improper use


CAUTION!
u Read these instructions for use before setting up and using the
product the first time.
u Observe the information on the safety of users and patients.
This document describes the correct cleaning and disinfection of
tonometer measuring prisms. Correct cleaning and disinfection
prevents the transmission of diseases to patients and users and
mechanical damage. This process has been validated by an
accredited testing laboratory to protect material and patients.

1.3 Questions and comments


u If you have questions or comments concerning these instruc-
tions for use or the device itself, contact ZEISS Service.
You can find the ZEISS contact partner for your country on the
following website: www.zeiss.com/med

1.4 Conventions in this document


Certain types of information are specially marked in this document
for better recognition.

1.4.1 Conventions in all text areas


• This is a list.
– This is a second level list.
This is a cross-reference: Questions and comments [} 5].
This is highlighted text.
This is software code or program text.
Names of software dialogs, fields or menus, and software
messages are marked by quotation marks:
• "View" menu.
• "Do you want to save the settings?"

319300-9231-000-AddGA01-GB-240320 5 / 18
1 Notes on the instructions for use Addendum
1.4 Conventions in this document Instructions for use and disinfection of
tonometer measuring prisms

The steps in menu and file paths are separated by slashes:


• "File / Save as"
• "My documents / Documents"
Keys, buttons, knobs, levers and other operating controls are
marked by square brackets:
• [START] key
• [Next] button

1.4.2 Conventions in a course of action

This is warning information about hazards that can cause


WARNING! death or severe injuries if not avoided.
The warning message names the possible consequences.
u This is a measure with which hazards can be prevented.

This is warning information about hazards that can cause


CAUTION! injuries if not avoided.
The warning message names the possible consequences.
u This is a measure with which hazards can be prevented.

This is warning information about hazards that can cause


NOTE property damages if not avoided.
The warning message names the possible consequences.
u This is a measure with which hazards can be prevented.
þ This is a requirement that must be met before the start of a
sequence of actions.
1. This is a command.
2. CAUTION! This is a warning message about hazards that
can occur during a single action. This is a command.
ð This is the result of a sequence of actions.

6 / 18 319300-9231-000-AddGA01-GB-240320
Addendum 2 Safety notes
Instructions for use and disinfection of 2.1 Ambient conditions
tonometer measuring prisms

2 Safety notes

2.1 Ambient conditions


Please follow the instructions of use for the appropriate devices.

2.2 Important general advice

Risk due to contaminated products


CAUTION!
Products listed in these instructions for use will not be shipped
disinfected. The use of these products can lead to patient injuries.
u Clean and disinfect the products in accordance with these
instructions for use prior to first use.
• Always follow all warnings and notes in the instructions for use
of the applanation tonometer and measuring prisms.
• Carry out examinations only with undamaged, cleaned and
disinfected measuring prisms.
• The measuring prisms used must not be damaged as they might
otherwise damage the patient’s cornea.
• Improper preparation can result in the transmission of diseases
to the patient and user as well as damage to the measuring
prisms.
• Residue from cleaning agents and disinfectants can irritate and
burn the patient’s eye.
• As a rule, the measuring prisms may be prepared together, but
should not be prepared with any other products.

2.3 Operation, environment


• The operation and preparation must only be performed by
qualified and trained personnel whose training is the responsi-
bility of the operator.
• Appropriate professional assessment and caution are necessary.
• The safety instructions in the instructions for use of the appla-
nation tonometers also apply.

2.4 Warranty and product liability


• The measuring prisms must be handled as described in the
Safety notes [} 7].
• Improper handling can damage the product. This voids all
guarantee claims.
• Continuing to use a product damaged by incorrect handling can
lead to personal injury. In this case, the manufacturer accepts
no liability.

319300-9231-000-AddGA01-GB-240320 7 / 18
2 Safety notes Addendum
2.5 Validated cleaning and disinfecting agents Instructions for use and disinfection of
tonometer measuring prisms

2.5 Validated cleaning and disinfecting agents


The following cleaning and disinfecting agents have been used in
several validations.

Cleaning agents
• Palmolive 0.08 %

Disinfectants
Product Concen- Exposure Rinsing
tration time
Hydrogen 3% 10 minutes Rinse with cold water
peroxide H2O2 for 5 minutes

Sodium 10 % 10 minutes Rinse with cold water


hypochlorite for 10 minutes
NaOCl

8 / 18 319300-9231-000-AddGA01-GB-240320
Addendum 2 Safety notes
Instructions for use and disinfection of 2.6 List of disinfectants with good material compatibility with ZEISS measuring
tonometer measuring prisms prisms

2.6 List of disinfectants with good material


compatibility with ZEISS measuring prisms
The disinfectants listed below were only tested on their material
compatibility with ZEISS measuring prisms.

Damage due to improper cleaning and disinfection


NOTE
The effectiveness of the disinfectants has not been tested for
correct disinfection of the tonometer measuring prisms.
The sole purpose of the list below is to provide the user with a
choice of suitable disinfectants which may be used for the
validation of their own disinfection process.
ZEISS rejects all liability if any of the disinfectants mentioned in the
list below is used without a proper validated cleaning and disin-
fection process.
The disinfectants may only be used with the concentration
mentioned on the list below. Higher concentrations can damage
the measuring prisms. In this case ZEISS rejects all liability.
ZEISS rejects all liability if a disinfectant is used which does not
appear on the list below.
u The efficacy of the disinfectants on ZEISS tonometer measuring
prisms must be guaranteed by the user or the responsible
person for reprocessing by validating their own disinfection
process.

319300-9231-000-AddGA01-GB-240320 9 / 18
2 Safety notes Addendum
2.6 List of disinfectants with good material compatibility with ZEISS measuring Instructions for use and disinfection of
prisms tonometer measuring prisms

Disinfectants Tested Alde- Contai- Comments


concentration hyde ning
free aldehyde
NaOCl 0.0525 % x
(sodium hypo-
chloride)

NaOCl 2.5 % x max.


(sodium hypo- 100 cycles of
chloride) 1h

NaOCl 10 % x max.
(sodium hypo- 100 cycles of
chloride) 1h

NaOH 1 M (1 mol/l) x max.


(sodium 100 cycles of
hydroxide) 1h

H2O2 (hydrogen 3% x
peroxide)

Acrylan® 1)
x

Almyrol® 4% x

Bodedex forte 1% x

Bomix plus 2% x

Cidex® plus 3.5 % x

Cidex® OPA 1)
x
1)
Dakin solution x

Deconex 53 2% x
Instrument

Deconex 53 Plus 4% x

Endo Septol FF 5% x

Gigasept ® AF 4% x

Gigasept ® AF 5% x
forte

Gigasept ® FF 8% x
NEW

Gigasept PAA 2% x
concentrate

Hibitane ® 0.5 % x

Jiaen 6 % 0.05 % x
"Yoshida"

Korsolex basic 5% x

10 / 18 319300-9231-000-AddGA01-GB-240320
Addendum 2 Safety notes
Instructions for use and disinfection of 2.6 List of disinfectants with good material compatibility with ZEISS measuring
tonometer measuring prisms

Disinfectants Tested Alde- Contai- Comments


concentration hyde ning
free aldehyde
Korsolex extra 4% x

Mucocit®-T 6% x

NU-CIDEX® 1)
x

PeraSafe® 1)
x

Peraxylens® 1)
x

Perfektan® active 2% x

Perfektan® TB 4% x

Sekusept® Activ 2% x

Sekusept® Activ 1)
x
NEU

Sekusept® forte S 3% x

Sekusept® PLUS 4% x

Stabimed® 2% x

Sterihyde® L 2% x
1)
Tristel DUO x
1)
Tristel Sporicidal x
Wipes
1)
Activated solution according to manufacturer's instructions

319300-9231-000-AddGA01-GB-240320 11 / 18
2 Safety notes Addendum
2.7 Service life Instructions for use and disinfection of
tonometer measuring prisms

2.7 Service life

How long can measuring prisms be used?

Risk of exceeding the maximum service life


CAUTION!
Exceeding the maximum service life of the tonometer measuring
prisms may result in injury to the patient.
u Do not use the measuring prisms beyond the expiration date.
u Immediately replace damaged measuring prisms.
Due to the large number of variables to be considered (type and
concentration of disinfectant used, number of patients, handling,
etc.) it is practically impossible to specify how often and/or long a
measuring prism can be used under safe conditions. The measuring
prisms carry an expiry date ( YYYY-MM). They must not be used
beyond this date. ZEISS recommends a maximum service life of two
years before the expiration date. This service life applies under
normal conditions of use, i.e. when used in accordance with the
instructions contained in this user manual. The service life starts
with the first use. The above periods do not apply for damaged
measuring prisms; these should be replaced immediately.

Year

First use Service life: replace


maximum two years
Service life:
maximum two years
Fabrication First use replace

Figure 1: Overview of the service life of the measuring prisms

12 / 18 319300-9231-000-AddGA01-GB-240320
Addendum 3 Cleaning and disinfection of reusable measuring prisms
Instructions for use and disinfection of 3.1 Manual cleaning steps
tonometer measuring prisms

3 Cleaning and disinfection of reusable


measuring prisms
Risk due to improper cleaning and disinfection
CAUTION!
The disinfectant used must satisfy two criteria:
u For material compatibility reasons, only agents approved by
ZEISS may be used. The current material compatibility list can
be found on the ZEISS homepage and is included with the
tonometer and the measuring prisms. Should the operator
decide to employ other disinfectants or procedures of his own
accord, it must be ensured that the disinfection is not
performed with agents containing alcohol or acetone and is
never performed with UV radiation, steam or ethylene oxide.
u In terms of the disinfection performance, all disinfectants that
are approved for instrument disinfection and that have been
tested for their efficacy against all nosocomially relevant infec-
tious agents can generally be used as long as they also satisfy
the material compatibility requirements outlined above. The
user is responsible for selecting the correct disinfectant and
employing the correct concentration.

Damage due to improper cleaning and disinfection


NOTE
The tonometer measuring prisms may be damaged during cleaning
and disinfection.
u Use only Hydrogen Peroxyde at a 3% aqueous solution or
Sodium Hypochlorite (Household Bleach) at a 10% aqueous
solution. These two solutions have been validated with mild
soap (e.g. Palmolive 0.08%) as the cleaning agent.

3.1 Manual cleaning steps


For simple and safe disinfection, we recommend using containers
with holders for several measuring prisms. In the following,
cleaning and disinfection using Desinset by HAAG-STREIT is
described. The use of other disinfection aids is at the user's own
risk. Used instruments must be rinsed off after use before the
residues dry up.

319300-9231-000-AddGA01-GB-240320 13 / 18
3 Cleaning and disinfection of reusable measuring prisms Addendum
3.2 Disinfection steps Instructions for use and disinfection of
tonometer measuring prisms

Action 1. Remove the measuring prisms from the tonometer holder (a)
and clean under running water (drinking water quality) (recom-
mended time 60 seconds).
2. Clean the measuring body with a pH-neutral cleaning agent
until no more dirt is visible.
3. The cleaning agent must then be rinsed off well under running
water (drinking water quality)! (recommended time 60 seconds)
(b).
4. Dry the measuring prisms with a lint-free disposable cloth (c).
5. Perform visual checks for cleanliness and perfect working
condition.
6. Place the cleaned measuring prisms in the Desinset plastic tray
(d).

3.2 Disinfection steps


We recommend the use of a validated disinfectant (see chapter
Validated cleaning and disinfecting agents [} 8]).
The operator accepts all liability for the use of other cleaning
agents.
The maximum, material-compatible exposure time for the disin-
fectant is 60 minutes.
Action 1. Take the measuring prisms to be disinfected out of the plastic
tray and place them on the lower tray (e) of a clean, disinfected
Desinset plastic insert.
NOTE! The measuring prisms must not overlap.
2. Add at least 600 ml of disinfectant solution (f), so that the
lower tray is completely immersed.
3. Place the disinfectant in one of the two Desinset measuring
beakers.
WARNING! All measuring prisms must be completely
immersed in the disinfectant solution. As the measuring
prisms tend to float in the solution, they must always be
placed in the lower tray of the Desinset insert.
4. Allow the disinfectant sufficient time to work as specified in the
disinfectant manufacturer’s instructions (g). The maximum,
material-compatible exposure time for the disinfectant is 60
minutes.
5. Once the exposure time has expired, remove the plastic insert
with the measuring prisms, allow it to drip dry (h) and then
place it in the other clean and disinfected measuring beaker.
The disinfectant must be replaced as follows:
• When visibly soiled.
• Once a day or as specified by the manufacturer.

14 / 18 319300-9231-000-AddGA01-GB-240320
Addendum 3 Cleaning and disinfection of reusable measuring prisms
Instructions for use and disinfection of 3.3 Rinsing and storage
tonometer measuring prisms

3.3 Rinsing and storage

Risk due to contaminated or damaged measuring prisms


CAUTION!
The patient may be injured by contaminated or damaged
measuring prisms.
u Never use damaged measuring prisms!
u Only use clean, residue-free and undamaged measuring prisms.
u Prior to every use, the contact surface of the measuring prism
must be inspected for contaminants and damage (scratches,
cracks or sharp edges). This must be performed with a slit lamp
microscope at a medium magnification (e.g. 12x or 16x).
Action 1. Place the clean and disinfected funnel on the plastic insert.
2. Rinse the measuring beaker and its contents with drinking-
water quality running water for at least 10 and at most 15
minutes (i).
3. Remove the plastic insert with the measuring prisms (j) and dry
the measuring prisms individually with a clean and sterile, soft,
disposable cloth (k).
4. Store the cleaned and disinfected measuring prisms in the
sealed and disinfected Desinset glass container (l) until their
next use.

319300-9231-000-AddGA01-GB-240320 15 / 18
3 Cleaning and disinfection of reusable measuring prisms Addendum
3.3 Rinsing and storage Instructions for use and disinfection of
tonometer measuring prisms

a b c d

e f g h

i j k l

Figure 2: Steps for cleaning, disinfection and rinsing

16 / 18 319300-9231-000-AddGA01-GB-240320
Empty page, for your notes
Carl Zeiss Meditec AG

Goeschwitzer Strasse 51-52

07745 Jena

Germany

Internet: www.zeiss.com/med

E-Mail: info.meditec@zeiss.com

Specifications subject to change

319300-9231-000-AddGA01-GB-240320
Empty page, for your notes
Carl Zeiss Meditec AG

Goeschwitzer Strasse 51-52

07745 Jena

Germany

Internet: www.zeiss.com/med

E-Mail: info.meditec@zeiss.com

Specifications subject to change

319300-9120-000-DokS-GB-240320

You might also like